CN107427685A - Attachment device for use with neural stimulation charging device and associated method - Google Patents

Abstract

Devices, systems, and methods for transcutaneous charging of implantable medical devices are provided herein. Such devices include a portable charging device and an attachment device for affixing the portable charging device to the skin of a patient in a suitable position and aligned over the implantable medical device to facilitate charging. The attachment device may include a frame having an opening through which the charging device is mounted and one or more tabs extending laterally from the opening, each tab including an adhesive surface and being movable from a first position extending away from the patient's skin to facilitate positioning of the charging device and a second position extending toward the patient's skin to engage the patient's skin and attach the charging device to the patient after being properly positioned.

Description

Attachment device for use with neural stimulation charging device and associated method

Cross References to Related Applications

This application claims priority to US Provisional Application No. 62/101,884, filed January 9, 2015, the entire contents of which are hereby incorporated by reference.

This application is related to the following U.S. Provisional Patent Application: U.S. Provisional Patent Application No. 62/2014, entitled "Devices and Methods for Anchoring of Neurostimulation Leads" 038,122; U.S. Provisional Patent Application No. 62, filed Aug. 15, 2014, entitled "External Pulse Generator Device and Associated Methods for Trial Nerve Stimulation" 038,131; Filed 25 August 2014 entitled "Electromyographic Lead Positioning and Stimulation Titration in a Nerve Stimulation System for Treatment of Overactive Bladder" and to the following U.S. Provisional Patent Application, all concurrently filed on January 9, 2015, entitled "Electromyographic LeadPositioning and Stimulation Titration in a Nerve Stimulation System for Treatment of Overactive Bladder" U.S. Provisional Patent Application No. 62/101,888 [Attorney Docket No. 97672-001210US] ; U.S. Provisional Patent Application No. 62/101,888, entitled "Integrated Electromyographic Clinician Programmer For Use With an Implantable Neurostimulator"; entitled "Systems and Methods for Neurostimulation Electrode Configurations Based on Neural Localization )”; U.S. Provisional Patent Application No. 62, entitled “Patient Remote and Associated Methods of Use With a NerveStimulation System” /101,666; and U.S. Provisional Patent Application No. 62/101,782, entitled "Improved Antenna and Methods of use for an Implantable Nerve Stimulator," said U.S. Provisional Patent Application Each of these is assigned to the same assignee as the present invention and is hereby incorporated by reference in its entirety for all purposes.

technical field

The present invention relates to neurostimulation treatment systems and associated devices; and methods of treatment, implantation and deployment of such treatment systems.

Background technique

In recent years, treatment with implantable neurostimulation systems has become more common. While such systems have shown promise in treating many conditions, therapeutic effectiveness may vary significantly between patients. Many factors can cause patients to experience very different outcomes, and it can be difficult to determine the feasibility of a treatment prior to implantation. For example, stimulation systems typically utilize electrode arrays to treat one or more target neural structures. The electrodes are typically mounted together on a multi-electrode lead, and the lead is implanted in the patient's tissue at a location intended to cause electrical coupling of the electrodes to the target neural structure, typically providing at least a portion of the coupling via intervening tissue . Other approaches may also be used, eg, one or more electrodes attached to the skin overlying the target nerve structure, implanted in a cuff around the target nerve, and the like. Regardless, the physician will typically attempt to establish an appropriate treatment regimen by varying the electrical stimulation applied to the electrodes.

Current stimulation electrode placement/implantation techniques and well known treatment setup techniques have significant disadvantages. Nervous tissue structure can vary widely from patient to patient, and it is challenging to accurately predict or identify the location and branching of nerves that perform specific functions and/or weaken specific organs. The electrical properties of the tissue structures surrounding the targeted neural structures may also vary widely among different patients, and neural responses to stimulation may affect bodily function in one patient with an effective reduction and potentially impose a significant Discomfort or pain, or electrical stimulation pulse pattern, pulse width, frequency, and/or amplitude that have limited effect on the other patient. Even in patients where the implantation of a neurostimulation system provides effective treatment, frequent adjustments and changes to the stimulation protocol are often required before an appropriate treatment program can be determined, often involving repeated visits and significant discomfort for the patient before results are achieved. While many complex and sophisticated lead configurations and stimulation setups have been implemented in an attempt to overcome these challenges, the variability in lead placement outcomes, clinician time to establish an appropriate stimulation signal, and discomfort imposed on the patient (and in some cases In some cases, significant pain) is still less than ideal. In addition, the relatively short lifetime and battery life of such devices necessitates routine replacement of the implanted system every few years, requiring additional surgery, patient discomfort, and significant expense to the medical system.

While rechargeable implantable devices have been investigated, the location and depth at which neurostimulation devices are implanted makes recharging such devices difficult. For example, neurostimulation devices are often implanted under a thin layer of muscle and fat tissue in the lower back region, allowing conventional approaches to utilize invasive techniques, such as recharging via percutaneous cables, or increased device size (which can cause Patient discomfort and limited mobility). Also, given the location where such a device is implanted - the lower back - it may be difficult, if not impossible, for the patient to perform attaching the rechargeable cord or device without the assistance of another person.

Given these shortcomings associated with conventional systems, the enormous benefits of these neurostimulation treatments have not yet been fully realized. Accordingly, it would be desirable to provide improved methods, systems and devices for facilitating recharging of implantable neurostimulation devices. It would be particularly helpful to provide such a system and method for recharging an implanted neurostimulation device in a non-invasive manner while increasing patient ease of use and improving patient comfort and comfort during charging. mobility.

Contents of the invention

The inventive systems, devices, and methods presented herein relate to transcutaneous charging of implantable medical devices. In particular, the present invention relates to devices and methods that facilitate positioning and alignment of a charging device and securing the charging device in place and/or aligning the charging device with the patient.

In one aspect, a rechargeable medical implant system according to an embodiment of the present invention includes an implantable medical device having a device for powering the device while implanted in a patient. a rechargeable power source and a wireless power receiving unit coupled to the rechargeable power source; a portable charging device having a wireless power transfer unit configured for communication with all of the implantable device magnetically coupled to the wireless power receiving unit for recharging the rechargeable power source; and a carrier removably coupled to the charging device, the carrier having a an adhesive surface on a skin surface, wherein the adhesive surface comprises a biocompatible adhesive having sufficient adhesive strength to adhere to the patient's skin surface and at least The carrier coupled to the charging device is supported for a duration sufficient to recharge the implantable medical device. The wireless power transfer unit of the charging device includes a charging coil configured for use when the charging device is at least partially engaged with the patient's skin surface and is at least partially positioned on the implantable A medical device is magnetically coupled to the wireless receiving unit, wherein the carrier secures the charging device substantially flat against the patient's skin.

In some embodiments, a carrier device according to aspects of the present invention comprises: one or more movable tabs having an adhesive surface disposed thereon, said one or more tabs Each of these is movable between a first position and a second position when the carrier is coupled with the charging device positioned against the patient's skin. In the first position, the one or more tabs are spaced from the patient's skin to facilitate manual positioning of the charging device along the patient's skin. In the second position, the one or more tabs are urged against the patient's skin to facilitate secure attachment of the carrier to the patient with the adhesive surface for the duration of the charge. the patient's skin.

In some embodiments, the carrier device includes one or more tabs extending at least partially circumferentially around the charging device when the carrier is coupled to the charging device , thereby securing the charging device substantially flat against the patient's skin when the carrier is adhered to the patient's skin. The carrier may include a frame to which one or more tabs are attached, wherein the frame defines a mounting interface at which the charging device is removably coupled. The mounting interface of the carrier is configured to allow manual rotation of the charging device relative to the carrier when the charging device is releasably coupled to the carrier.

In one aspect, the carrier includes a mounting interface provided with a size fit allowing rotation of the charging device when the charging device is subjected to a moment force and for maintaining the charging device when the charging device is static. sufficient friction for the angular fixation of the charging device within the carrier. In some embodiments, the charging device is defined by a circular or disc-shaped housing supporting and/or enclosing the wireless power transfer unit and at least partially within the housing. The associated charging coil inside the protruding circular portion. The frame of the carrier includes a circular ring and the mounting interface includes a ridge along an inner edge of the circular ring that abuts an outer edge of the protruding portion of the charging device. The mount may be configured to resiliently receive the protruding circular portion of the charging device within a snap.

In some embodiments, the carrier device comprises three or more tabs arranged circumferentially around a central frame of the device and extending laterally outward from the frame, each tab being movable in the first position deflected from the second position. In one aspect, the tab is formed from a sufficiently rigid and flexible material to resiliently flip (through the center) between the first position and the second position. The frame and the one or more tabs may be integrally formed of a polymeric material and may be disposable.

In one aspect, the carrier device includes a coupling interface releasably coupled to the charger device and has one or more removable tabs having An adhesive portion attached to the patient's skin, the adhesive portion being detached from the charger device. In some embodiments, the adhesive portion is disposed on the one or more tabs such that the adhesive portion does not contact a surface of the charging device. This arrangement is advantageous because it avoids the build-up of residual adhesive on the charger device, which can be reused over many charging sessions.

In another aspect, the charger device may be disposable, the adhesive portion providing a secure attachment to the patient at least for a sufficient duration to charge the device. The carrier device can then be easily removed from the charger device and discarded or recycled after the charging period is complete. In some embodiments, the carrier device is provided to the patient with one or more pads disposed over the adhesive portion to preserve and protect the adhesive until ready for use. A single substrate extending over the entire adhesive portion may be used such that the charger device may be secured and removed thereby exposing the entire adhesive portion. In some embodiments, the patient is provided with a plurality of disposable carrier devices, such as a stack of carrier devices.

In another aspect, provided herein is a carrier device for a portable charging device configured for transcutaneously charging a neurostimulator device in a patient. Such a carrier device may be defined by a semi-rigid or rigid frame configured for removably coupling with the charging device, wherein the frame includes an opening through which the charging device is coupled when the charging device is coupled to the frame. a portion of the charging device extends through the opening; and one or more tabs are attached to the frame and extend laterally outward from the opening of the frame, wherein the one or more tabs comprising an adhesive surface having a biocompatible adhesive having sufficient adhesive strength to adhere to the patient's skin surface The carrier coupled to the charging device is supported for a duration in which the neurostimulator is recharging. Each of the one or more tabs is movable between a first position and a second position when the carrier is coupled with the charging device positioned against the patient's skin, wherein at the In the first position, the one or more tabs are spaced from the patient's skin to facilitate manual positioning of the charging device along the patient's skin, and in the second position, the The one or more tabs are advanced against the patient's skin to facilitate secure attachment of the carrier to the patient's skin using the adhesive surface for the duration of the charging. Such a carrier device may comprise any of the features described in the above system.

In some embodiments, the charging device carrier comprises a frame defined by a circular ring having a circular opening sized to snugly receive the circular protrusion of the charging device having the charging coil therein part. The carrier includes one or more tabs disposed circumferentially about the opening, the one or more tabs extending laterally outward such that when the charging device is coupled to the carrier and the tabs Adhering to the skin of the patient supports and maintains the charging device substantially flat against the patient's skin.

Also provided herein are methods of percutaneously charging an implanted medical device in a patient according to aspects of the invention. The method includes the steps of removably coupling a portable charging device having a housing and a charging coil disposed therein to a carrier having one or more tabs having a biocompatible adhesive surface, the one or a plurality of tabs are movable between a first position and a second position; when the charging device is installed in the carrier and the one or more tabs are in the first position and the patient non-invasively engaging a bottom surface of the charging device at least partially against the skin surface of the patient when the skin surface is spaced apart; positioning the charging device until it is at least partially positioned on the on or near the implantable medical device; and moving the one or more tabs from the first position to the second position such that the adhesive surface contacts and adheres to the patient The skin is sufficient to support the charging device coupled to the carrier for a duration sufficient to charge the implanted device.

In some embodiments, positioning the charging device includes moving the charging device near the implanted device along the skin surface of the patient until the charging device outputs an indication to the patient The charging device is properly positioned for user feedback. Typically, said first warning may be audible and/or tactile user feedback. The method may further comprise rotating the charging device relative to the carrier while the one or more tabs secure the carrier to the skin surface of the patient until the charging device is in contact with the patient. The implantable device is rotationally aligned, which may be indicated by user feedback, such as a second warning. In one aspect, the patient's single hand is utilized to perform each of the following providing improved patient comfort and ease of use: aligning the bottom surface of the charging device with the patient's skin engaging; positioning the charging device; rotating the charging device relative to the carrier; and moving the one or more tabs to the second position.

In some embodiments, the charging device carrier includes a strap. The straps may be formed from a breathable and stretchable material and include corresponding coupling features on each opposite end adapted to releasably couple to one another to allow the patient to attach the straps as desired. The above belt is adjusted to the middle section. A circular hole may be arranged in the middle part of the belt. The circular aperture is sized to snugly receive the protruding circular portion of the portable charging device. A semi-rigid or rigid frame defines the circular aperture and has a mounting interface adapted for removably coupling with the charging device such that the protruding circular portion of the charging device Protrudes through the circular aperture and engages the patient's skin when the charging device is coupled to the strap worn on the midsection of the patient. In some embodiments, the mounting interface is axisymmetric about a normal axis extending through the center of the circular hole, thereby allowing the patient to manually rotate the charging device when it is coupled to the strap to a specific rotational alignment.

In some embodiments, a method of transcutaneously charging an implanted medical device in a patient includes removably coupling a portable charging device having a housing and a charging coil to a carrier strap having a circular aperture, thereby Such that the circular bottom portion protrudes through the hole when coupled. A bottom surface of the charging device is at least partially engaged against the patient's skin surface when the charging device is mounted within the carrier strap. The charging device is positioned by the patient until at least partially positioned on or near the implantable medical device, as indicated by a first audible and/or tactile signal from the charging device. The strap is adjusted by releasably coupling corresponding coupling features on opposite ends of the strap. The strap may be positioned before, during or after the patient has positioned the charging device. The method may further include manually rotating the charging device while the charging device is coupled within the band until the second audible and/or tactile signal indicates an acceptable charging alignment for charging.

In one aspect, a method of transcutaneously charging an implanted medical device in a patient includes using a different indicator (e.g., an audible and/or tactile alert) to assist a user in recharging the implanted device with a portable charging device. Charge medical devices. Such a method may include: placing a portable charger device on the patient to facilitate charging an implanted neurostimulator in the patient; positioning the portable charger device until the charging device is charged to the patient. the patient outputs a first indicator indicating that the charging device is proximate or properly positioned over the implantable device for charging; and adjusting the the location of the portable charger device or an attachment device supporting the charger device; and removing the charging device after a third indication indicating charging is complete is output by the charging device. Typically, each of the first, second and third indicators is unique so as to be easily identifiable by the patient. Each of said first, second and third indicators may be an audible and/or tactile warning. In some embodiments, the first warning is a sustained tone. The second indicator may be a periodic vibration and/or a series of short tones, such as three beeps and vibrations repeated every few seconds. The third indicator may comprise a series of repeated short tones different from the second indicator, for example, a repeated series of rising tones, the series of repeated short tones is used to warn the patient that charging is complete so that The charging device can be removed.

In another aspect, an implantable medical device and a portable charging device having an indicator graphic for visually representing the relative Target alignment for medical devices. Such a system may include an implantable medical device having a rechargeable power supply for powering the device while implanted in a patient and a rechargeable power supply coupled to the rechargeable power supply. a wireless power receiving unit; and a portable charging device having a wireless power transmitting unit configured to be magnetically coupled with the wireless power receiving unit of the implantable device for charging the The rechargeable power supply is used for recharging. The portable charging device may include a planar surface for engaging the patient's skin over the implanted medical device to facilitate charging. The indicator graphic may be provided on the planar surface and/or on the opposite outwardly facing surface and represent the charging device relative to the implantable medical device to facilitate the patient's charging of the charging device. Target alignment for alignment. The indicator may be a graphic having the size and shape (e.g., outline) of the implanted medical device, which may serve as information to the patient regarding the charging device relative to the implanted medical device. A visual cue or reminder of a desired alignment. The system may further include a carrier device for supporting a charging device in a desired alignment, such as any of the embodiments described herein.

Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating various embodiments, are intended for purposes of illustration only and are not intended to necessarily limit the scope of the disclosure.

Description of drawings

Figure 1 schematically illustrates a neurostimulation system including a clinician for positioning and/or programming both a trial neurostimulation system and a permanently implanted neurostimulation system, in accordance with aspects of the present invention programmer and patient remote.

2A-2C show diagrams of neural structures along the spine, lower back, and sacral region that may be stimulated in accordance with aspects of the present invention.

Figure 3A illustrates an example of a fully implantable neurostimulation system in accordance with aspects of the present invention.

3B illustrates an example of a neurostimulation system with a partially implanted stimulation lead for trial stimulation and an external pulse generator bonded to the patient's skin, in accordance with aspects of the present invention.

4 illustrates an example of a neurostimulation system having an implantable stimulation lead, an implantable pulse generator, and an external charging device, in accordance with aspects of the present invention.

5A-5C illustrate detailed views of an implantable pulse generator and associated components for a neurostimulation system, in accordance with aspects of the present invention.

6A illustrates a charging device configured for transcutaneous, wireless charging of an implantable neurostimulation device, in accordance with aspects of the present invention.

Figure 6B illustrates an accessory for charging a portable charging device in accordance with aspects of the invention.

6C-6D illustrate another portable charging device and an associated docking station for charging the device, respectively, in accordance with aspects of the invention.

7A illustrates an attachment device including an adhesive carrier adapted for use with a portable charging device, in accordance with aspects of the present invention.

Figure 7B illustrates another attachment device including a strap, in accordance with aspects of the invention.

Figure 7C illustrates another attachment device including a strap, in accordance with aspects of the invention.

FIGS. 8A-8B illustrate manual coupling of an adhesive carrier device with adhesive tabs to the portable charging device of FIG. 6C , in accordance with aspects of the present invention.

8C-8D illustrate cross-sections of an adhesive carrier device with an adhesive tab in a first position and a second position, according to aspects of the invention.

9A-9C illustrate a method of transdermally charging an implantable medical device using a carrier device according to aspects of the present invention.

Figure 10 illustrates an example of a charging device placed on an implanted IPG in accordance with aspects of the present invention.

11A-11C illustrate a method of transdermally charging an implantable medical device using a carrier device according to aspects of the present invention.

12 illustrates a method of transdermally charging an implantable medical device by rotating the device to provide optimal alignment, in accordance with aspects of the present invention.

Fig. 13 schematically illustrates a method of transdermally charging an implantable medical device using a carrier device according to aspects of the present invention.

14A-14B schematically illustrate a method of facilitating transcutaneous charging of an implanted medical device through the use of various indicators or warnings from the charging device, in accordance with aspects of the present invention.

Figure 15 schematically illustrates a method of transdermally charging an implantable medical device using a charging device that outputs various indicators to a patient, in accordance with aspects of the present invention.

16 illustrates a charging device having a graphical indicator representing the target alignment of the charging device relative to the implantable medical device, in accordance with aspects of the present invention.

detailed description

The present invention relates to neurostimulation treatment systems and associated devices; and methods of treatment, implantation/placement and deployment of such treatment systems. In particular embodiments, the present invention relates to a sacral nerve stimulation treatment system configured to treat and relieve symptoms associated with bladder dysfunction, including overactive bladder ("Overactive Bladder, OAB"), and bowel dysfunction . In addition, the instructions herein can also be used to treat other forms of urinary dysfunction and treat fecal dysfunction, so throughout this specification, it should be understood that what has been described for OAB is also applicable to other forms of urinary dysfunction and stool dysfunction. disfunction. However, it will be appreciated that the present invention may also be used for any kind of neuromodulation use (such as bowel dysfunction), treatment of pain, or other indications, such as movement disorders or affective disorders, as will be understood by those skilled in the art .

I. Neurostimulation Indications

Neurostimulation (or neuromodulation as used interchangeably hereinafter) therapy systems (e.g., any of the neurostimulation therapy systems described herein) can be used to treat a wide variety of diseases and associated Symptoms (eg, acute pain disturbances, movement disturbances, affective disturbances, and bladder and bowel-related dysfunction). Examples of pain disorders treatable by nerve stimulation include failed lumbar spine surgery syndrome, reflex sympathetic dystrophy or complex regional pain syndrome, causalgia, arachnoiditis, and peripheral neuropathy. The motor sequence includes muscle paralysis, tremor, dystonia, and parkinsonism. Affective disorders include depression, obsessive-compulsive disorder, cluster headaches, Tourette's syndrome, and certain types of chronic pain. Bladder-related dysfunction includes, but is not limited to, OAB, urge incontinence, urgency-frequency, and urinary retention. OAB can include urge incontinence and urgency-frequency, alone or in combination. Urge incontinence is the involuntary loss or loss of urine (urgency) associated with a sudden, intense urge to pass. Urgency-frequency is the frequent, often uncontrollable desire to urinate (urgency), usually resulting in the excretion of very small amounts (frequency). Urinary retention is the inability to empty the bladder. Neurostimulation therapy may be configured to treat a particular condition or associated symptom by administering neural stimulation to target neural tissue related to sensory and/or motor control associated with the condition.

In one aspect, the methods and systems described herein are particularly suited for the treatment of urinary and fecal dysfunction. The medical community has historically been unaware of these conditions and is remarkably underserved. OAB is one of the most common urinary disorders. It is a complex condition characterized by the presence of troublesome urinary symptoms including urgency, frequency, nocturia, and urge incontinence. It is estimated that approximately 40 million Americans have OAB. In the adult population, about 16 percent of all men and women suffer from OAB symptoms.

OAB symptoms can have a significant negative impact on a patient's psychosocial functioning and quality of life. People with OAB often limit activities and/or develop coping strategies. Furthermore, OAB imposes a significant financial burden on individuals, their families, and healthcare institutions. The prevalence of comorbid conditions in patients with OAB is significantly higher than in the general population. Comorbidities can include fall fractures, urinary tract infections, skin infections, vulvovaginitis, cardiovascular disease, and central nervous system pathology. Chronic constipation, fecal incontinence, and overlapping chronic constipation occur more frequently in patients with OAB.

Conventional treatment of OAB usually includes lifestyle changes as a first course of action. Lifestyle changes include eliminating bladder irritants (eg, caffeine) from foods, managing fluid intake, reducing body weight, stopping smoking, and managing bowel regularity. Behavior modification includes changing voiding habits (eg, bladder training and delayed voiding), training the pelvic floor muscles to improve urethral sphincter strength and control, biofeedback, and techniques for desire suppression. Drugs are considered second-line treatment for OAB. These drugs include anticholinergics (oral, skin patches, and gels) and oral beta3-adrenergic agonists. However, anticholinergic drugs are often associated with troublesome systemic side effects (eg, dry mouth, constipation, urinary retention, blurred vision, lethargy, and confusion). The study found that more than 50% of patients discontinued anticholinergics within 90 days due to lack of efficacy, adverse events, or cost.

When these modalities are successful, third-line treatment options recommended by the American Urological Association include intradetrusor (bladder smooth muscle) injection of botulinum toxin (BTX), percutaneous tibial nerve stimulation (PTNS), and sacral nerve stimulation (SNM). BTX is provided via intra-detrusor injection under cystoscopy guidance, but repeated BTX injections every 4 to 12 months are usually required to maintain effect, and BTX can undesirably cause urinary retention. Many randomized controlled studies have shown some effects of BTX injections in patients with OAB, but the long-term safety and efficacy of BTX on OAB is largely unknown.

PTNS treatment consisted of weekly 30-minute sessions (over a 12-week period), each session using electrical stimulation delivered from a hand-held stimulator to the sacral plexus via the tibial nerve. For patients who respond well and continue treatment, continued courses (usually every 3 to 4 weeks) are required to maintain remission. If the patient fails to adhere to the treatment schedule, there is a chance that the effectiveness will be reduced. The effects of PTNS have been demonstrated in few randomized controlled studies, however, data on the effectiveness of PTNS beyond 3 years are limited and are not useful for seeking cure for urge urinary incontinence (UUI) (eg, 100% reduction in incontinence episodes) (EAU guidelines ) patients, PTNS is not recommended.

II. Sacral Neuromodulation

SNM is an established treatment that provides a safe, effective, reversible and durable treatment option for urge incontinence, urgency-frequency and non-obstructive urinary retention. SNM treatment involves stimulating the sacral nerves located in the lower back with gentle electrical pulses. The electrodes are placed next to the sacral nerves (usually at the S3 level) by inserting the electrode leads into the corresponding holes in the sacrum. Electrodes are inserted subcutaneously and then attached to an implantable pulse generator (IPG). The safety and efficacy of SNM for OAB treatment (including durability over five years in urge incontinence and urgency-frequency patients) is supported and well documented by multiple studies. SNM is also approved for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatment.

A. Implantation of the Sacral Neuromodulation System

Currently, SNM qualification is in a trial phase and, if successful, followed by permanent implantation. The trial phase is a test stimulation period during which the patient is allowed to assess whether the treatment is effective. Generally, there are two techniques for performing test stimuli. The first technique is an office-based procedure called percutaneous neuroevaluation (PNE), and the other technique is a phased trial.

In PNE, the needle is usually used first to identify the optimal stimulation site (usually at S3 level) and to assess the integrity of the sacral nerve. Motor and sensory responses were used to verify correct needle placement as described in Table 1 below. Then, a temporary stimulating lead (monopolar electrode) is placed near the locally anesthetized sacral nerve. This procedure can be performed in an office setting without the need for fluoroscopy. A temporary lead is then connected to an external pulse generator (EPG) taped to the patient's skin during the trial phase. Stimulation levels can be adjusted to provide an optimal level of comfort for a particular patient. The patient will monitor his or her discharge for 3 to 7 days to see if there is any improvement in symptoms. The advantage of PNE is that it is an incisionless procedure that can be performed in a physician's office using local anesthesia. Disadvantages are that the temporary lead is not securely anchored in place and has a tendency to migrate away from the nerve with physical activity and thereby cause treatment failure. If a patient fails this trial test, the physician may still recommend a staged trial as described below. If the PNE test is positive, the temporary test lead is removed and a permanent quadrupole tine lead is implanted under general anesthesia along with the IPG. Other neuromodulation applications may have any number of electrodes and more than one lead as therapy may require.

The phased trial involved implanting a permanent quadrupole tine stimulation lead into the patient from the start. It also requires the use of pins to identify the nerve and optimal stimulation location. A lead is implanted near the S3 sacral nerve and connected to the EPG via a lead extension. This procedure is performed in the operating room, under the guidance of fluoroscopy, and under local and general anesthesia. The EPG is adjusted to provide the patient with an optimal level of comfort, and the patient monitors his or her excretion for up to two weeks. If the patient achieves meaningful improvement in symptoms, he or she is considered a suitable candidate for permanent implantation of the IPG (usually in the upper buttock region as shown in Figures 1 and 3A) under general anesthesia.

Table 1: Motor and sensory responses of SNM at different sacral nerve roots

* Clamping: contraction of the anal sphincter; and in males, retraction of the base of the penis. Move the hips aside and look for anterior/posterior shortening of the perineal structures.

Canal: Lifting and lowering of the pelvic floor. Look for deepening and flattening of the gluteal cleft.

With regard to measuring the efficacy of SNM treatment on voiding dysfunction, voiding dysfunction indications (eg, urge incontinence, urgency-frequency, and non-obstructive urinary retention) were assessed by a single primary voiding diary variable. These same variables were used to measure treatment efficacy. SNM treatment was considered successful if a minimum 50% improvement in any of the major voiding diary variables occurred compared to baseline. For urge incontinence patients, these voiding diary variables may include: number of leaks per day, number of severe leaks per day, and number of pads used per day. For patients with urgency-frequency, key voiding diary variables may include: the number of voids per day, the volume of each void, and the degree of urgency experienced prior to each void. For patients with retention, key voiding diary variables may include: catheterization volume per catheterization and number of catheterizations per day. For FI patients, efficacy measures captured by the voiding diary included: number of leak events per week, number of leak days per week, and degree of urgency experienced prior to each leak.

The motor mechanism of SNM is multifactorial and affects the nerve axis at several different levels. In patients with OAB, it is believed that pelvic and/or pudendal afferents may activate an inhibitory reflex that promotes bladder storage by inhibiting the afferent limb of the abnormal voiding reflex. This blocks input to the pontine voiding center, thereby limiting involuntary detrusor contractions without interfering with normal voiding patterns. In patients with urinary retention, SNM is thought to activate pelvic and/or pudendal afferents originating from the pelvic organs into the spinal cord. At the spinal level, these afferents can initiate the voiding reflex by inhibiting the overprotective reflex, thereby alleviating symptoms in patients with urinary retention and thus promoting normal voiding. For patients with fecal incontinence, it is hypothesized that SNM stimulates pelvic and/or pudendal afferent fibers that inhibit colonic propulsion activity and activates the internal anal sphincter, which in turn improves symptoms in fecal incontinence patients. The present invention relates to nerves (which may be the same or different from the stimulation target) adapted for use in nerves (which may or may not be the same as the stimulation target) resulting in partial or complete activation of target nerve fibers, resulting in control of organs and structures associated with bladder and bowel function. A system that delivers neural stimulation to target neural tissue by means of enhancement or inhibition of neural activity.

B. Localization of nerve stimulation leads using EMG

While conventional sacral nerve stimulation modalities have demonstrated efficacy in the treatment of bladder and bowel-related dysfunction, improvements are needed in the positioning of nerve stimulation leads and between trial and permanent placement of leads consistency. Neurostimulation relies on the consistent delivery of therapeutic stimulation from a pulse generator to a specific nerve or target area via one or more neurostimulation electrodes. Neurostimulation electrodes are provided on the distal end of the implantable lead that can be advanced through a tunnel formed in the patient's tissue. Implantable neurostimulation systems offer a great deal of freedom and mobility to the patient, but it may be easier to adjust the neurostimulation electrodes of such a system before they are surgically implanted. It is desirable for the physician to confirm that the patient has the desired motor and/or sensory responses prior to implanting the IPG. For at least some treatments, including treatment of at least some forms of urinary and/or fecal dysfunction, demonstration of appropriate motor responses can be very beneficial for accurate and objective lead placement, and sensation may not be required or available Reaction (eg, patient is under general anesthesia).

Placing and aligning the nerve stimulation electrodes and implantable leads close enough to a particular nerve may be beneficial for the efficacy of the therapy. Accordingly, aspects and embodiments of the present disclosure relate to assisting and improving the accuracy and precision of neurostimulation electrode placement. Further, aspects and embodiments of the present disclosure are directed to facilitating and improving schemes for setting therapeutically processed signal parameters for stimulation programs implemented by implantable neurostimulation electrodes.

Before a permanent device is implanted, patients may undergo an initial testing phase in order to assess potential response to treatment. As described above, PNE can be done under local anesthesia, using a test needle to identify the appropriate sacral nerve(s) based on the patient's subjective sensory response. Other testing procedures may involve a two-stage surgical procedure in which a quadrupole tine lead is implanted for a test phase (first stage) in order to determine whether the patient exhibits sufficient frequency of symptom relief, and Where appropriate, proceed with permanent surgical implantation of neuromodulation devices. For test phases and permanent implants, determining the location of lead placement may depend on subjective qualitative analysis by either or both of the patient or physician.

In an exemplary embodiment, determining whether the implantable leads and nerve stimulation electrodes are in the desired or correct position may be accomplished using electromyography ("EMG"), also known as surface electromyography. EMG is the technique of using an EMG system or module to evaluate and record the electrical activity produced by muscles, producing a recording known as an electromyogram. When muscle cells are activated electrically or nerves, EMG detects the electrical potentials generated by those cells. The signal can be analyzed to detect the level of activation or phase of recruitment. EMG can be performed through the patient's skin surface, intramuscularly, or through electrodes placed in the patient's body close to the target muscle, or using a combination of external or internal structures. When a muscle or nerve is stimulated by electrodes, EMG can be used to determine whether the relevant muscle is activated in response to the stimulation (ie, whether the muscle is fully contracted, partially contracted, or not contracted). Accordingly, the degree of activation of the muscle may indicate whether the implantable lead or neurostimulation electrode is in a desired or correct location on the patient's body. Further, the degree of activation of the muscle may indicate whether the neurostimulation electrodes are providing stimulation of sufficient intensity, amplitude, frequency or duration to implement a therapeutic regimen on the patient's body. Thus, the use of EMG provides an objective and quantitative means by which to standardize placement of implantable leads and neurostimulation electrodes, reducing subjective assessment of patient sensory responses.

In some approaches, the site titration process may optionally be based in part on paresthesia or pain-based subjective responses from the patient. In contrast, EMG triggers measurable and discrete muscle responses. Since therapeutic efficacy typically relies on precise placement of neurostimulation electrodes at target tissue locations and constant repeated delivery of neurostimulation therapy, the utility and success of SNM therapy can be greatly enhanced using objective EMG measurements. Depending on the stimulation of the target muscle, the measurable muscle response may be partial or complete muscle contraction, including responses below the triggering of observable motor responses as shown in Table 1. Furthermore, by utilizing a trial system that allows the neurostimulation leads to remain implanted for use with a permanently implanted system, the effects and efficacy of the permanently implanted system are more consistent with the results of the trial period, which in turn leads to improved patient outcomes. Moreover, the ability of the EMG systems described herein to quantitatively sense partial contractions may facilitate the use of localization and/or programming stimulation levels lower than those appropriate for reliable subjective assessment by the patient. Thus, pain associated with electrode positioning and/or programming can optionally be reduced or eliminated through the use of sub-subjective EMG stimulation signals, wherein the programming and/or positioning of some embodiments substantially, substantially, predominantly, or even Rely entirely on the sub-subjective stimulus signal.

C. Example Neurostimulation System

Figure 1 schematically illustrates exemplary neurostimulation systems, including a trial neurostimulation system 200 and a permanently implanted neurostimulation system 100, in accordance with aspects of the present invention. Each of the EPG 80 and the IPG 10 is compatible and wirelessly communicates with a clinician programmer 60 and a patient remote control 70 for controlling the trial nerve stimulation system 200 and/or (Following a successful trial) the permanently implantable system 100 is positioned and/or programmed. As discussed above, the clinician programmer may include dedicated software, dedicated hardware, and/or both to aid in lead placement, programming, reprogramming, stimulation control, and/or parameter setting. Additionally, each of the IPG and EPG allows the patient to have at least some control over stimulation (eg, initiate a preset program, increase or decrease stimulation) and/or monitor battery status using a patient remote. This approach also allows for an almost seamless transition between pilot and permanent systems.

In one aspect, clinician programmer 60 is used by a physician to adjust EPG and/or IPG settings while the lead is implanted in the patient. The clinician programmer may be a tablet computer used by the clinician to program the IPG or control the EPG during the trial period. The clinician programmer may also include the ability to record stimulus-evoked EMG to facilitate lead placement and programming. The patient remote control 70 may allow the patient to turn stimulation on or off, or to change the stimulation from the IPG when implanted or from the EPG during the trial phase.

In another aspect, the clinician programmer 60 has a control unit which may include a microprocessor and special purpose computer code instructions for implementing a clinical physician for deploying the treatment system and setting treatment parameters. methods and systems. The clinician programmer typically includes a user interface (which may be a graphical user interface), an EMG module, electrical contacts (such as an EMG input that may be coupled to an EMG output stimulation cable), an EMG stimulation signal generator, and a stimulation power supply . The stimulation cable may be further configured to couple to any or all of an access device (eg, a bore), a therapy lead of the system, and the like. The EMG input may be configured to couple with one or more sensory patch electrodes for attachment to the patient's skin proximate a muscle (eg, a muscle weakened by a target nerve). Other connectors of the clinician programmer may be configured for coupling to an electrical ground or ground patch, an electrical pulse generator (eg, EPG or IPG), or the like. As noted above, the clinician programmer may include a module having hardware or computer code for performing EMG analysis, wherein the module may be part of a control unit microprocessor, coupled to a stimulus and/or Feel the cable or the preprocessing unit connected to it, etc.

In some aspects, the clinician programmer is configured to operate in conjunction with the EPG when the leads are placed in the patient. The Clinician Programmer can be coupled to the EPG wirelessly or electronically via a dedicated cable set, and during test simulation. And allows the clinician programmer to configure, modify or otherwise program the electrodes on the leads connected to the EPG.

Electrical pulses generated by the EPG and IPG are delivered to one or more target nerves via one or more nerve stimulating electrodes at or near the distal end of each of the one or more electrodes. Leads can have a variety of shapes, can be a variety of sizes, and can be made of a variety of materials, which can be customized for a particular therapeutic application. While in this embodiment the lead wire is of a size and length suitable for extending from the IPG and through one of the holes in the sacrum to the target sacral nerve, in various other applications the lead wire may be implanted, for example, peripherally in the patient's body part (eg, in an arm or leg), and can be configured to deliver electrical impulses to peripheral nerves such as can be used to relieve chronic pain. It should be understood that leads and/or stimulation programs may vary depending on the nerve being targeted.

2A-2C show illustrations of various neural structures of a patient that may be used for neurostimulation therapy, in accordance with aspects of the present invention. Figure 2A shows the different segments of the spinal cord and the corresponding nerves within each segment. The spinal cord is an elongated bundle of nerves and supporting cells that extends from the brainstem along the cervical cord, through the thoracic cord, and to the space between the first and second lumbar vertebrae in the lumbar cord. After leaving the spinal cord, the nerve fibers split into branches that innervate the various muscles and organs that transmit sensory and control impulses between the brain and the organs and muscles. Because some nerves can include branches that innervate certain organs, such as the bladder, and branches that innervate certain muscles in the legs and feet, stimulation of nerves at or near the nerve roots near the spinal cord can stimulate nerve branches that innervate target organs, This may also result in a muscle response associated with stimulation of another nerve branch. Thus, by monitoring certain muscle responses (such as those in Table 1) visually, by using EMG as described herein, or both, a physician can determine whether a target nerve is being stimulated. While a certain level of stimulation may elicit a robust muscle response visible to the naked eye, lower levels of stimulation can still provide activation of organs associated with the target organ while eliciting no corresponding muscle response or only a response visible using EMG . In some embodiments, such low level stimulation may also not cause any paresthesias. This is advantageous because it allows for the treatment of a condition through nerve stimulation without otherwise causing patient discomfort, pain, or undesired muscle responses.

Figure 2B shows the nerves associated with the lower back segment in the lower lumbar region where nerve tracts exit the spinal cord and travel through the sacral foramen of the sacrum. In some embodiments, the nerve stimulation lead is advanced through the hole until the nerve stimulation electrode is positioned at the root of the anterior sacral nerve, and the anchor portion of the lead proximal to the stimulation electrode is typically placed in the sacral foramen through which the lead passes. dorsal side to anchor the leads in place. Figure 2C shows a detailed view of the nerves of the lumbosacral trunk and sacral plexus (specifically, the S1 to S5 nerves of the lower sacrum). The S3 sacral nerve is of particular interest for the treatment of bladder-related dysfunction (and OAB in particular).

FIG. 3A schematically illustrates an example of a fully implantable neurostimulation system 100 adapted for sacral nerve stimulation. The neurostimulation system 100 includes an IPG implanted in the lower back region and connected to a neurostimulation lead extending through the S3 foramen in order to stimulate the S3 sacral nerve. The leads are anchored by a tine-shaped anchoring portion 30 (which maintains the position of a set of nerve stimulation electrodes 40 along the target nerve, which in this example is the anterior nerve innervating the bladder). Sacral nerve root S3) in order to provide treatment for various bladder-related dysfunctions. While this embodiment is adapted for sacral nerve stimulation, it should be appreciated that a similar system could be used to treat patients with, for example, chronic, severe, refractory neuropathic pain originating from peripheral nerves or various urinary functions. Obstacles or patients who are still further indicated for other indications. Implantable neurostimulation systems can be used to stimulate targeted peripheral nerves or the posterior epidural space of the spine.

The characteristics of the electrical pulses can be controlled via a controller of the implanted pulse generator. In some embodiments, these characteristics may include, for example, frequency, amplitude, pattern, duration, or other aspects of electrical pulses. These characteristics may include, for example, voltage, current, and the like. Such control of electrical pulses may include creating one or more electrical pulse programs, programs or patterns, and in some embodiments this may include selecting one or more pre-existing electrical pulse programs, programs or modes. In the embodiment depicted in FIG. 3A , implantable neurostimulation system 100 includes a controller in the IPG with one or more pulse programs, schedules, or patterns that can be reprogrammed or created in the manner discussed above. In some embodiments, these same characteristics associated with the IPG may be used in the EPG of a partially implanted trial system used prior to implantation of the permanent neurostimulation system 100 .

Figure 3B shows a schematic diagram of a trial neurostimulation system 200 utilizing an EPG patch 81 adhered to the patient's skin (specifically, attached to the patient's abdomen), with the EPG 80 encased within the patch. In one aspect, the leads are hardwired to the EPG, while in another aspect the leads are movably coupled to the EPG through ports or apertures in the top surface of the flexible patch 81 . Excess leads can be secured with additional adhesive patches. In one aspect, the EPG patch can be arranged such that the lead can be disconnected and used in a permanently implanted system without moving the distal end of the lead away from the target location. Alternatively, the entire system is deployable and can be replaced with permanent leads and IPGs. As previously discussed, when an experimental system lead is implanted, EMG obtained via the clinician programmer using one or more sensor patches can be used to ensure that the lead is placed in close proximity to the target nerve or muscle. location.

In some embodiments, the experimental neurostimulation system utilizes an EPG 80 within an EPG patch 81 that is bonded to the patient's skin and coupled to an implantable neurostimulation lead 20 through a lead extension 22 via a connector 21 is coupled with lead 20 . This extension and connector configuration allows extension of the lead so that the EPG patch can be placed on the abdomen and, if the trial proves successful, allows the use of a lead of a length suitable for permanent implantation. This approach may utilize two percutaneous incisions, the first in which the connector is provided and the lead extension extending through the second percutaneous incision with a short tunneling distance (eg, about 10 cm) between them. This technique also minimizes movement of the implanted lead during conversion of the experimental system to a permanently implanted system.

In one aspect, the EPG unit is controlled wirelessly by the patient remote control and/or the clinician programmer in a similar or identical manner to the IPG of a permanently implanted system. Physicians or patients can change the treatment provided by the EPG by using this portable remote control or programmer, and the delivered treatment is recorded on the programmer's memory for use in determining whether it is suitable for use in a permanently implanted system. treatments used in . In each of the trial and permanent neurostimulation systems, the clinician programmer can be used for lead placement, programming, and/or stimulation control. In addition, each neurostimulation system allows patients to use a patient remote control to control stimulation or monitor battery status. This configuration is advantageous because it allows for an almost seamless transition between the pilot system and the permanent system. From the patient's point of view, the system will operate in the same way and the system will be controlled in the same way, making the patient's subjective experience with the trial system the same as what he would experience with a permanently implanted system match more closely. Thus, this configuration reduces any uncertainty the patient may have about how the system will operate and be controlled, making it more likely that the patient will convert the experimental system to a permanent system.

As shown in the detailed view of FIG. 3B , EPG 80 is encased within a flexible layered patch 81 that includes an aperture or port through which EPG 80 is connected to lead extension 22 . The patch may further include an "on/off" button 83 with molded tactile details for allowing the patient to switch the EPG on and/or off by adhesive patch 81 on the outer surface. The underside of the patch 81 is covered with a skin compatible adhesive 82 for continuous attachment to the patient for the duration of the test session. For example, a breathable strip with skin-compatible adhesive 82 would allow the EPG 80 to remain continuously attached to the patient during a trial, which may last more than a week (typically two to four weeks) or even longer .

FIG. 4 illustrates an example neurostimulation system 100 that is fully implantable and adapted for sacral nerve stimulation therapy. The implantable system 100 includes an IPG 10 coupled to a neurostimulation lead 20 that includes a set of neurostimulation electrodes 40 at the distal end of the lead. The lead includes a lead anchoring portion 30 having a series of tines that extend radially outward to anchor the lead and maintain the position of the nerve stimulation lead 20 after implantation. Lead 20 may further include one or more radiopaque markers 25 to aid in placement and positioning of the lead using visualization techniques such as fluoroscopy. In some embodiments, the IPG provides unipolar or bipolar electrical pulses delivered to target nerves through one or more nerve stimulating electrodes. In the case of sacral nerve stimulation, a lead is typically implanted through hole S3 as described herein.

In one aspect, the IPG can be wirelessly recharged by conductive coupling using a charging device 50 (CD), which is a portable device powered by a rechargeable battery, to allow patient mobility while charging. The CD was used to transcutaneously charge the IPG by RF induction. An attachment device such as an adhesive carrier 1 or a tape 9 can be used to stick the CD on the patient's skin. The CD can be charged by inserting the CD directly into an outlet or by placing the CD in a charging cradle or station 55 connected to an AC wall outlet or other power source.

As shown in the schematic diagram of the neurostimulation system in FIG. 6, the system may further include a patient remote 70 and a clinician programmer 60, each configured for use with an implanted IPG (or wireless communication with EPG) during the period. Clinician programmer 60 may be a tablet computer used by clinicians to program the IPG and EPG. The device also has the capability to record stimulus-evoked electromyography (EMG) to facilitate lead placement, programming and/or reprogramming. The patient remote may be a battery powered portable device that utilizes radio frequency (RF) signals to communicate with the EPG and IPG and allow the patient to adjust stimulation levels, check the status of the IPG battery levels, and/or turn stimulation on or off.

5A-5C show detailed views of the IPG and its internal components. In some embodiments, the pulse generator may generate one or more non-ablative electrical pulses that are delivered to the nerve to control pain or cause some other desired effect (e.g., to inhibit, block, or interrupt nerve activity), thereby treating OAB or bladder-related dysfunction. In some applications, pulse amplitude ranges between 0 mA and 1,000 mA, between 0 mA and 100 mA, between 0 mA and 50 mA, between 0 mA and 25 mA, and/or any other or intermediate amplitude range of pulses may be used. One or more of the pulse generators may include a processor and/or memory adapted to provide instructions to and receive information from other components of the implantable neurostimulation system. Processors can include such things as from or AMD Microprocessors such as commercially available microprocessors, etc. The IPG may include energy storage features such as one or more capacitors, one or more batteries, and often includes a wireless charging unit.

One or more characteristics of the electrical pulses may be controlled via a controller of the IPG or EPG. In some embodiments, these characteristics may include, for example, frequency, intensity, pattern, duration, or other timing and amplitude aspects of electrical pulses. These characteristics may further include, for example, voltage, current, and the like. Such control of electrical pulses may include creating one or more electrical pulse programs, programs or patterns, and in some embodiments this may include selecting one or more pre-existing electrical pulse programs, programs or modes. In one aspect, IPG 10 includes a controller having one or more pulse programs, schedules or patterns that can be created and/or reprogrammed. In some embodiments, the IPG can be programmed to vary stimulation parameters (including pulse amplitude ranging from 0 mA to 10 mA, pulse width ranging from 50 μs to 500 μs, pulse frequency ranging from 5 Hz to 250 Hz , stimulation mode (eg, continuous or cyclic), and electrode configuration (eg, anode, cathode, or off)) in order to achieve patient-specific optimal therapeutic efficacy. In particular, this allows optimal settings to be determined for each patient (even though each parameter may vary from person to person).

As shown in FIGS. 5A and 5B , the IPG may include a head portion 11 at one end and a ceramic portion 14 at the opposite end. The head portion 11 houses the feedthrough assembly 12 and the connector stack 13, while the ceramic shell portion 14 houses the wireless charging coils for facilitating wireless charging with clinician procedures, patient remote controls, and/or for facilitating wireless charging using a CD. Antenna assembly 16 for communications. The remainder of the IPG is covered by a titanium shell portion 17 that encloses the printed circuit board, memory and controller components that facilitate the electrical pulse procedure described above. In the example shown in FIG. 5C , the header portion of the IPG includes a four-pin feedthrough assembly 12 coupled to a connector stack 13 in which the proximal ends of the leads are coupled. The four pins correspond to the four electrodes of the neurostimulation lead. In some embodiments, The connection block was electrically connected to four platinum/iridium alloy feedthrough pins which were brazed to an alumina ceramic insulator plate along with titanium alloy flanges. This feedthrough assembly is laser seam welded to the titanium-ceramic brazed shell to form a complete hermetic enclosure for the electronics. The number of electrical contacts on the head is a function of the number of electrodes and leads used for any particular system configuration.

In some embodiments, such as that shown in Figure 5A, a ceramic and titanium brazed shell is utilized on one end of the IPG where the ferrite coil and PCB antenna assembly is positioned. A reliable hermetic seal is provided via Ceramic-to-Metal brazing technology. Zirconia ceramics may include 3Y-TZP (3 mol% yttria stabilized tetragonal zirconia polycrystalline) ceramics, which have high flexural strength and impact resistance and have been used commercially in many implantable medical technologies. However, it will be appreciated that other ceramics or other suitable materials may be used to construct the IPG.

In one aspect, the utilization of ceramic material provides an efficient radio frequency transparent window for wireless communication with external patient remote controls and clinician's programmers since the communication antenna is housed within the hermetic ceramic shell. While maintaining an effective radio-frequency transparent window for long-term and reliable wireless communication between the IPG and external controllers (such as patient remote controls and clinician programmers), this ceramic window has further facilitated the implant miniaturization. Unlike prior art products, where the communication antenna is placed in the head outside the airtight enclosure, the IPG's wireless communication is generally stable over the lifetime of the device. The communication reliability of such prior art devices tends to degrade due to time-dependent changes in the dielectric constant of the head material in the human body.

In another aspect, the ferrite core is part of the charging coil assembly 15 shown in FIG. 5B positioned within the ceramic housing 14 . The ferrite core concentrates the magnetic field flux through the ceramic shell opposite the metal shell portion 17 . This configuration maximizes coupling efficiency, which reduces the required magnetic field and thereby reduces device heating during charging. Specifically, heating during charging is minimized because the magnetic field flux is oriented in a direction perpendicular to the smallest metal cross-sectional area. This configuration also allows the use of the CD at a depth of 3 cm (when the CD is positioned on the patient's skin surface close to the IPG) to efficiently charge the IPG and reduce recharge time.

FIG. 6 shows a setup for test simulation and EMG sensing using clinician programmer 60 . As discussed above, clinician programmer 60 is a tablet computer with software running on a standard operating system. Clinician programmer 60 includes a communication module, a stimulation module, and an EMG sensing module. The communication module communicates with the IPG and/or EPG in a medical implant communication service frequency band to program the IPG and/or EPG.

In order to confirm proper lead placement, it is desirable for the physician to confirm that the patient has adequate motor and sensory responses before transitioning the patient into a phased trial phase or implanting a permanent IPG. However, sensory responses are subjective assessments and may not always be available (eg, when the patient is under general anesthesia). Experiments have shown that exhibiting an appropriate motor response is beneficial for accurate placement (even if a sensory response is available). As discussed above, EMG is a tool for recording the electrical activity of skeletal muscles. Such sensory characteristics provide clinicians with objective criteria for judging whether sacral nerve stimulation results in adequate motor responses, rather than relying solely on subjective sensory criteria. EMG can be used not only to verify optimal lead placement during lead placement, but also to provide a standardized and more accurate way to determine electrode thresholds, which in turn provides quantitative information supporting electrode selection for programming. Using EMG to verify activation of the motor response may further improve lead placement performance for inexperienced operators and allow such physicians to perform lead placement with confidence and more accuracy.

In one aspect, the system is configured with EMG sensing capabilities that may be particularly valuable during reprogramming. Stimulation levels during reprogramming are usually low in order to avoid patient discomfort which often makes it difficult to generate motor responses. Involuntary muscle movements while the patient is awake may also cause noises that are difficult for physicians to distinguish. EMG allows clinicians to detect motor responses at very low stimulation levels (eg, sub-threshold) compared to conventional means, and helps them distinguish motor responses originating from sacral nerve stimulation from involuntary muscle movements.

Referring to Figure 6, several sets of cables are connected to the clinician programmer. The stimulation cable set consists of a stimulation mini-clamp 3 and a ground patch 5. It is used in conjunction with the bore needle 1 to locate the sacral nerve and verify the integrity of the nerve via test stimulation. Another stimulation cable set with four stimulation channels 2 is used to verify lead position using tine stimulation leads 20 during phased trials. Since both cable sets will be in the sterile field, they are sterilizable. A total of five on-rack sense electrode patches 4 (e.g., two sense electrode pairs and one common ground patch for each sense point) are provided for use in two different EMG sensing is performed at muscle groups such as the perineal musculature and the big toe. This provides the clinician with a convenient all-in-one setup via the EMG integrated clinician programmer. Typically, only one electrode set (eg, two sensing electrodes and one ground patch) is required to detect EMG signals on the big toe during initial electrode configuration and/or reprogramming. Typically, these on-rack EMG electrodes are provided with sterility, although not all cables are required to be connected to the sterile field. Clinician programmer 60 allows the clinician to read the impedance of each electrode contact whenever leads are connected to the EPG, IPG, or clinician programmer to ensure a reliable connection is made and the leads are intact. Clinician programmer 60 is also capable of saving and displaying previous (eg, up to the last four) procedures that the patient has used to help facilitate punch programming. In some embodiments, clinician programmer 60 further includes a USB port and a charging port for saving reports to a USB drive. The clinician programmer may also include a physical on/off button for turning the clinician programmer on and off and/or for turning stimulation on and off.

III. Charging the Fully Implanted Neurostimulation System

In one aspect, a neurostimulation system according to the present invention is fully implantable and powered by a rechargeable battery that allows the system to be cycled only by an external CD for the life of the device. sexual transdermal charging to provide therapy. This feature increases the useful life of the neurostimulation system compared to conventional neurostimulation systems that use non-rechargeable batteries that must be removed during surgery and replaced every three to four years. This conventional approach for a fully implanted neurostimulation system obviously causes a great deal of discomfort and inconvenience to the patient. Furthermore, many patients may be reluctant to undergo treatments that require periodic surgical intervention every few years. In contrast, a neurostimulation system utilizing transcutaneous charging according to the principles described herein allows such a system to function for up to 10 years or more without invasive intervention to replace batteries, thereby improving patient comfort and acceptance of implantable neurostimulation therapy.

In one aspect, the systems and methods provide for transdermal charging of implanted devices through wireless charging that uses electromagnetic fields to transfer energy between two objects. This method uses a charging station or device that sends energy through magnetic or inductive coupling to an energy receiving unit of the implanted device, which then uses that energy to charge a battery in the implanted device. This method of charging typically uses an external device having: a charging coil that generates an alternating electromagnetic field within the charging unit; and a second coil in the implanted device in which the electromagnetic field is It then switches back to current to charge the battery. The coils typically must be in close proximity to form a power transformer, and remain close for a duration sufficient to fully charge the battery. In many conventional devices, the coil is configured such that the coil must be placed in close proximity, usually less than a few centimeters. While greater distance wireless charging can be achieved through various other methods, such as resonant inductive coupling, these methods may require precise alignment between coils, while other approaches may require coils to have increased size and/or or high power charging. Wireless charging may be further understood by reference to US Patent No. 6,972,543 entitled "Series resonant inductive charging circuit," which is incorporated herein by reference for all purposes.

The aspects of wireless charging noted above present significant challenges to charging implanted medical devices, as it is desirable that such devices be able to have reduced size and weight and minimize patient exposure to high powered charging stations . These aspects of wireless charging are extremely challenging for implantable neurostimulation devices, which are typically implanted at a deeper depth (such as a depth of about 3 cm) in the patient's lower back under a thin layer of muscle and/or adipose tissue. In such cases, the placement and/or alignment of the external charging device may not be readily accessible or visible to the patient. Given the challenges associated with wireless charging of implantable neurostimulation devices, conventional neurostimulation devices have used non-rechargeable batteries with approximately three to four year lifetimes. While this approach avoids the drawbacks noted above, the patient is also subjected to periodic invasive surgical procedures whenever the battery needs to be replaced.

In one aspect, the system and charging method of the present invention overcome these challenges associated with wireless charging due in part to the unique construction of the wireless receiving unit of the neurostimulation device and external CD and also through the use of specific features that enhance This improves the positioning of the external CD and its alignment with the implanted device allowing for more robust, consistent charging of the implanted device. Furthermore, the features described herein allow the patient to achieve that precise positioning and alignment relatively easily without the assistance of a caregiver or medical personnel. Furthermore, the above goals are provided, but still allow for reduced size and weight of the implantable neurostimulation device while maintaining patient mobility through the use of a portable external charging device that remains attached to the patient during charging.

In one aspect, the systems and methods described herein allow for complete implantation within a sustained period of time (typically less than hours, such as within two hours or less) by a portable external charging device adhered to the patient using an attachment device. Transcutaneous charging of neurostimulation devices. In one aspect, the attachment device is adapted to allow the patient to place the external CD in a position and/or alignment suitable for wireless charging and to maintain that position and/or alignment during charging. Examples of such attachment devices are shown in Figures 7A-7C and are described further below.

A. Implanted battery charging protocol

In some embodiments, the IPG of the neurostimulation system includes a charging coil adapted to capture the energy necessary to charge the internal battery. The battery voltage is measured by the IPG's digital-to-analog (A/D) converter and is also monitored by a battery monitor during charging. A battery monitor compares the battery voltage to a voltage reference. Based on the battery monitor output, the current charger inside the implant is controlled accordingly. When the battery voltage is about 3.0V, it is in normal charging mode. Set the charging current to the default value -25mA(C/2). Charging will stop when the battery voltage reaches 4.05V to prevent overcharging. To charge the battery with a battery voltage between 2.5V and 3.0V, a smaller charging current (-2.5V) is used until it reaches 3.0V (in which case the battery enters normal charging mode). In some embodiments, the IPG charging circuitry is designed in such a way that recharging is not possible when the battery voltage is below 2.5V to prevent potential thermal runaway from causing a rapid rise in battery temperature, although this is due to overdischarge The low capacity of the battery is not possible. Field tests have demonstrated that such batteries can be safely recharged from a very low voltage state (0.1V). It is a very rare occurrence that the battery voltage drops below 2.5V, because when the battery voltage drops below 3.0V, the IPG will be forced into sleep mode, during which time, the battery may consume only a small leakage current, making the battery voltage It will take over a year to go from 3.0V to below 2.5V. In some embodiments, the implanted battery has a capacity of 50 mAh, allowing the IPG to last nearly two weeks at the OAB's normal stimulation settings before requiring a recharge.

In some embodiments, the external CD is a moving puck-shaped device configured to provide wireless and transcutaneous recharging and/or Alignment on the patient. The CD includes a microcontroller that handles charging control and communication with the IPG. The CD also includes a battery that can be recharged at a charging station or by coupling directly to a power source, which allows the patient to be recharged while on the move. The CD is shaped and sized to fit comfortably in the patient's finger to facilitate placement of the CD on the patient for recharging and to allow the patient to prepare the CD for disposal. In some embodiments, the CD includes a temperature sensor to ensure that the charger will never overheat. The charger monitors the battery charge status and automatically disconnects the implanted battery when it is fully charged.

In one aspect, the CD is a portable device with an enlarged upper portion and a protruding circular portion on its underside. The enlarged upper portion, which typically includes a rechargeable battery and associated electronics and microcontroller, is sized for ease of user grip to facilitate patient handling and positioning of the CD. The protruding circular portion houses the charging coil and includes a substantially planar surface for engaging the patient's skin over the implantable IPG. While a CD is depicted as a puck-shaped device, it should be appreciated that various other shapes may be used to define a CD while still providing certain features of the aspects described herein.

FIG. 6A shows an example of an external portable CD 50 according to the aspect described above. The CD includes a disc-shaped upper portion containing a rechargeable battery that can support continuous charging for at least 2 hours. This section also includes an on/off button, and an indicator light 52 indicates the charger battery status. Various colors or flashes can be used to indicate different states. For example, a green light indicates that the charger battery is in a good state of charge and should provide a full charge (for example, up to 2 hours) for a depleted IPG battery; an amber light indicates that the charger battery has energy to provide a limited charge but may Not enough to fully charge a depleted IPG battery. A blinking amber light indicates that the CD has insufficient charge (even partial charge) to the IPG. The indicator flashes green while the CD is charging. The indicator is only illuminated when the CD is on; the indicator is off when the CD is off. The rounded portion 53 of the bottom extends outward so that the charging coil can be brought closer to the IPG to facilitate deeper charging, eg a depth of greater than 2 cm, typically up to a depth of about 3 cm.

The CD can be charged through a variety of options, such as those in Figure 6B showing a designated charging station 55, USB power cord 57, and can utilize a USB power adapter 58 to connect to a wall outlet or an electrical outlet in a car use together.

FIG. 6C shows another example CD 50 including a disc-shaped upper portion with indicator lights 52 and a protruding circular bottom portion (not shown). In this embodiment, the upper portion includes flattened sides that facilitate handling and rotational orientation by the patient, as further described below. Figure 6D shows a charging station 55 utilizing a circular recess for receiving a protruding circular portion of a CD 50 to facilitate charging by a charging coil housed therein.

In some embodiments, the patient needs to remove the CD to the implanted IPG in order to begin recharging. The CD provides audio feedback to assist the patient in finding the IPG. The audio transducer audibly indicates when the IPG is bringing the charging coil close to the IPG. When the CD is close to the IPG (enough to detect but not within the charging area), the CD emits three short beeps and one long beep to indicate that the CD is within the IPG charging area.

Optionally, the patient will then rotate the CD to achieve better angular alignment. Provides tactile feedback when optimal angular alignment is achieved between CD and IPG. Audio tones to signal notifications are now charging the IPG through the CD. Additionally, periodic green flashes on the CD indicate that charging is currently in progress. If optimal alignment is not achieved within 15 seconds, but the charging field is strong enough to charge the implanted battery, the charging process will continue and the audio will be turned off. If the charger moves during charging and the charging field disappears completely, the CD will emit 3 short beeps (although not yet within range of the IPG charging zone). This warns the user that the CD is off target and needs to be relocated on the IPG. When charging is complete, the CD provides an indication to the user that charging is complete and power down. For example, the CD may output a unique series of audio tones (eg, three short beeps) indicating the end of charging, and a flashing green light will turn off. In some embodiments, a watchdog timer is used to verify that the microcontroller is operational. In the event of a program failure, the microcontroller will enter a safe state (de-energize or de-energize the coil).

By utilizing the devices and charging methods described herein, IPGs can be recharged at deeper depths, such as about 3 cm. Having a deeper charging depth allows for improved patient comfort during charging (as it allows placement of the implant in the desired location within the tissue), while still allowing percutaneous wireless charging with a portable CD. However, in order to efficiently recharge as described, precise position and/or alignment of the CD must be achieved and reasonably maintained for the duration necessary to complete the IPG battery charge. This can be accomplished using various attachment methods and devices adapted for use with CDs, such as those shown and described below.

B. Example Attachment Device

In one aspect, the carrier device includes a frame releasably coupleable to the CD and has a plurality of outwardly extending tabs having a shape suitable for adhesively attaching the CD to the CD. Pressure sensitive adhesive secured to the patient's skin. The frame is configured to allow the CD to directly contact the patient's skin on the implanted IPG so as to minimize the distance between the CD and the implanted IPG.

Figure 7A shows such a carrier device adapted for use with a CD 50, according to an embodiment of the present invention. In this example, the CD 50 has a disc-shaped housing 51 that is circular in shape and includes a circular protrusion 53 in which a charging coil is at least partially arranged. The carrier 1 is defined by a frame 2 having a circular opening 3 through which said circular portion 53 can be inserted and mounted into the carrier 1 . The carrier 1 comprises a plurality of tabs 5 , for example three tabs, arranged circumferentially around the frame 2 and extending laterally outwards from the opening in which the CD 50 is mounted. Each tab comprises an adhesive surface 6 having an adhesive for bonding the carrier to the patient's skin upon contact. The adhesive is a biocompatible pressure sensitive adhesive having sufficient adhesive strength to attach the carrier to the patient's skin and at least as long as the device is filled. The CD 50 mounted in the carrier 1 is supported for a desired duration. The charging duration can range from about 30 minutes to 5 hours, typically about 2 hours or less.

On the other hand, the carrier 1 comprises a mounting interface 4 via which the CD 50 is releasably coupled with the carrier 1 . In some embodiments, mounting interface 4 engages a corresponding mounting feature 54 of CD 50 to securely couple CD 50 within carrier 1 while still allowing rotation of CD 50 relative to the charging device. In this example, the mounting interface 4 is a flange or ridge, and the corresponding mounting feature 54 is a groove extending around the circular protrusion 53 . The CD 50 is releasably coupled to the carrier 1 in preparation for insertion into the circular protrusion 53 through the mounting hole 3 for charging until the lip 4 is matingly received in the corresponding slot 54 . It should be appreciated that since the carrier couples with the CD along a mounting interface arranged around the lobes, such a carrier may be used with a CD having an upper housing designed in a variety of other shapes, such as in FIG. 6C CDs or CDs with a non-circular shaped upper case.

Figure 7B shows an alternative carrier or attachment device comprising a cuff 9 adapted for attaching the CD at a desired location and/or aligning it on the patient for charging. Such an annulus can be configured in a variety of different sizes depending on the location of the desired attachment location on the patient. For example, in order to charge an IPG implanted in a patient's lower back, the cuff can be sized to have a cuff that is similar in size to a strap so as to extend at least partially around the patient's wrist while position to support the CD and/or align at the lower back. For other neurostimulation therapy where the IPG is implanted in various other locations (eg, upper arm or chest), the cuff 9 can be sized as an upper arm cuff or as a holster for extending across the chest.

Figure 7C shows yet another alternative carrier comprising an adjustable strap 9' with couplings at opposite ends that allow the patient to adjust the strap as desired (typically to fit the patient's midsection) Features 9a and 9b. The strap 9' may be formed from a breathable and stretchable fabric, increasing patient comfort during charging. The coupling features 9a, 9b may be docking features (e.g., snaps, hooks and loops, ), or any suitable coupling means. The strap 9' further comprises an annular hole 3 through which the protruding circular portion 53 of the CD 50 can be inserted so that when the strap is worn, the CD 50 can be maintained in the lower back area to support the implant for the duration of the charge. In-type IPG for charging. This location is particularly suitable for use with the sacral neuromodulation system described herein, although it should be appreciated that such a strap could be used on the chest or in various other locations as desired for various other types of therapy systems. The strap 9' may comprise a semi-rigid or rigid frame 2 arranged around a circular hole 3 including a mounting interface 4 that is releasably interfaced with a corresponding interface (e.g. a snap or tongue interface) of the CD 50. ground coupling. In this embodiment, the mounting interface 4 is axisymmetric about a normal axis passing through the center of the circular hole so that the CD 50 can preferably be rotated by 180 degrees or more to allow for coupling within the belt 9' while rotating CD 50. As in other embodiments described herein, the mounting interface may be configured with sufficient resistance to hold the position of the CD in once the CD is rotated into the desired position.

Figures 8A-8B show a patient mounting an example CD 50 in the carrier 1, similar to that shown in Figure 7A. The patient positions the carrier 1 with the adhesive surface of the tab 5 facing away from the CD 50 and then inserts the protruding circular bottom portion 53 of the CD 50 through the circular hole 3 of the carrier 1 . Using two hands, the user can then press both the upper disc-shaped housing of the CD 50 and the carrier frame 2 until the mounting interface 4 snaps into the corresponding interface 54 of the CD 50 . The patient can then depress tab 50 to move frame 2 into the reverse configuration (if not already in the reverse configuration). The substrate disposed on each of the adhesive portions of the tab 5 can then be removed, and the planar engagement surface of the lobe 53 of the CD 50 can then be applied to the body and conditioned. Positioning (as described further below).

8C to 8D show a cross-section of an adhesive carrier device, similar to that of FIG. 7A , having a frame 2 with a mounting hole 3 extending therethrough and laterally from the frame 2. A plurality of tabs 5 extending outward. The tab is movable between a first position (shown in FIG. 8C ) and a second position (shown in FIG. 8D ). As shown in FIG. 8C , the tabs in said first position extend upwards away from the plane P along which the frame 2 of the carrier extends. The tab in said first position is angled upwardly, typically 90 degrees or less, preferably about 45 degrees or less, even more preferably about 30 degrees. This upward angling provides clearance for the CD 50 mounted in the carrier through the hole 3 while maintaining the adhesive surface 6 in contact with the CD when the CD mounted in the carrier 1 is placed on the patient's skin during initial positioning of the CD. The patient's skin is spaced apart. FIG. 8D shows the carrier 1 with the tabs 5 extending in the opposite direction relative to the plane P in a second position for engaging the patient's skin with the attachment portion 6 . The tabs in the first position are angled downward a' (the angle being less than 45 degrees, preferably about 30 degrees or less) so as to engage the patient's skin while maintaining the CD mounted therein against the patient's skin .

In one aspect, the carrier includes one or more tabs rigid enough to maintain the first and second positions when static, yet flexible enough to bend slightly to The material conforms to the patient's skin when in the second position, thereby maintaining the CD 50 mounted in the carrier 1 against the patient's skin during charging time.

In one aspect, the carrier includes a spring-type mechanism or feature that facilitates ready deployment of the plurality of adhesive tabs into engagement with the patient's skin when the charger device is in a suitable charging position, such as May be indicated by audible and/or tactile signals from the charging device. This configuration is advantageous in a sacral neuromodulation system where the IPG is implanted in the lower back region and the patient is using a single hand to position the charging device in the lower back region. In response to audible and/or tactile signals output from the charging device indicating a suitable charging location, the patient may effect deployment of the plurality of adhesive tabs through a spring-type mechanism or feature of the charging device carrier. This action can be achieved by pressing the carrier with the fingers of a single hand, for example by pressing a button or lever of the carrier or by pressing a single tab. In some embodiments, the spring-type feature is provided by the design of the carrier frame itself. The carrier frame may comprise a semi-rigid or rigid material having a standard configuration and a reverse configuration from which the frame resiliently springs toward the standard configuration.

In one such embodiment, the carrier 1 comprises a frame configured with: a standard configuration, in which the tab 5 is in the second position; and a reverse configuration, in which , the web 5 is in the first position. Applying a slight force to one or more tabs in the first position in the direction of the arrow shown in FIG. 8C causes the land 5 to move quickly or bounce from the first position to the second position. In some embodiments, the tabs are interconnected by a frame such that applying such a force to one tab causes the carrier to move from the reversed configuration to the normal configuration in substantially the same manner as a reversed contact lens springs from the reversed state to its normal shape. configure. In some embodiments, the tabs may be continuous around the frame and flexible enough to move between the standard configuration and the reverse configuration. This configuration is advantageous because it allows the patient to place the CD 50 mounted in the carrier 1 and position the CD 50 on the implantable device 10 with a single hand, and by pointing to the tabs with the fingers of the same hand. A slight force is applied to achieve rapid movement of the tab from the first position to the second position, thereby engaging the adhesive surface 6 with the patient's skin and attaching the carrier and CD in the desired position. The patient then aligns the CD 50 with the implantable device 10 by using the same hand to rotate the CD 50 mounted in the carrier 1 attached to the patient's skin.

9A to 9K illustrate a method of charging using a CD installed in the carrier 1 according to the embodiments of the present invention described herein. FIG. 9A depicts a CD 50 resting in its charging station 55 with a visual status indicator 52 indicating that the device is charged and ready to charge an implanted device (eg, green light). When the CD 50 is removed from the charging station 55 (as shown in Figure 9B), the CD is automatically turned on. The user then releasably couples or mounts the CD 50 within the carrier 1 by inserting the CD through the frame 2 of the adhesive carrier device 1, so that the circular portion of the CD is arranged at the first position of the movable tab 5. Extends through frame 2 when in position, as shown in Figure 9C. With the CD 50 properly installed in the carrier 1, the patient removes any film present on the adhesive portion 6 of the tab and orients the CD 50 towards the implantable device 10, as shown in Figure 9D. The patient then places the portion of the CD that protrudes through the carrier 1 in contact with the patient's skin S generally close to the implantable device 10, as shown in Figure 9E. In some embodiments, the CD detects the presence of a nearby IPG 10 and may output user feedback, such as a visual, audio or tactile indicator, that the IPG 10 is in range but off target.

As shown in FIG. 9E , the patient then positions the CD on the IPG 10 by moving the CD 50 along the skin S with the tab 5 of the carrier in the first position so that the adhesive portion 6 is spaced from the patient's skin. Open to avoid attachment to the patient until the CD is properly positioned. Once the CD is properly positioned on the IPG 10 (as shown in Figure 9F), the CD can output user feedback indicating that the CD is in the best charging position. The user feedback will typically be an audio or tactile warning, as the patient may not be able to see the visual indicator when the CD is glued to the patient's lower back. When properly placed, the distance d between the charging coils in the CD 50 is minimized. In many applications, such as sacral neuromodulation therapy, the IPG 10 is implanted at a depth of approximately 3 cm such that when an adhesive carrier is used to maintain the CD 50 against the skin, the distance d between the charging coil and the IPG 10 is About 3cm.

FIG. 10 shows top views of several different alignments of CD 50 on implantable IPG 10, shown in dashed lines. In this embodiment, the optimal charging position is CD 50 directly on IPG 10 in a particular rotational alignment. An example of an improper position (which may be indicated by an audible/tactile signal or without a user feedback signal) is shown on the right. It should be appreciated that, in some embodiments, even if IPG 10 is not quite in optimal alignment, CD 50 may still signal that the proximity is sufficient for charging (although less ideal alignments may require longer charging cycles) .

11A-11C illustrate the steps taken once lateral positioning of the CD 50 is performed, as described in FIGS. 9D-9F. Once properly positioned, the patient attaches the CD 50 to his skin by moving the tabs 5 of the carrier 1 from the first position to the second position such that the adhesive surface engages the patient's skin. This is usually done with the patient using the palm of his hand by flipping down the upper edge of the tab in the direction of the arrow shown in Figure 11A to hold the CD against the skin, which moves the tab into contact with the patient's skin The second position of engagement, thereby attaching the CD to the patient's skin S at the appropriate charging location on the IPG 10, as shown in FIG. 11B . The patient can then remove the support for his hand, and the adhesive surface holds the CD in place.

Once the CD is properly positioned and attached to the patient's skin, the patient can adjust the rotational alignment of the CD. In one aspect, the carrier is configured such that the CD can be manually rotated while mounted within it yet sufficiently secured so that the CD does not rotate when the CD is static (that is, when no moment is applied to the CD) . This can be accomplished by providing a mounting interface that allows rotation but provides enough friction to prevent undesired rotation (when the device is not manually rotated by the patient). As shown in Figure 1 IB, the patient rotates the CD 50 within the carrier until the CD is properly aligned, as detected by the CD and communicated to the patient via user feedback. Typically, this user feedback is a second tactile and/or audio alert. This alert can be different or the same as the first alert. The patient then allows the CD to remain in place for a duration sufficient to allow the device to be charged, typically at least one hour, such as about two hours. In some embodiments, the CD is configured to provide user feedback, such as a third warning, communicated to the patient that charging is complete and the CD and its disposed carrier can be removed. Figure 12 shows a top view of the rotational adjustment CD 50 with the tabs 5 of the carrier still firmly adhered to the patient's skin S.

FIG. 13 illustrates a method of charging using an adhesive carrier according to an embodiment of the present invention. The method includes the steps of: releasably coupling a CD configured for transcutaneously charging an implantable powered medical device with a carrier having one or more tabs, the one or more tabs having an adhesive for bonding to the patient's skin, 130; coupling the patient's skin with the carrier coupled to the carrier when the one or more tabs are spaced apart from the patient's skin in the first position engaging the charging device, and positioning the charging device until at least partially positioned on or near the implantable medical device, 131; moving the one or more tabs from the first position to a second position, such that the adhesive surface adheres to the skin of the patient sufficient to support the CD coupled to the carrier for a duration sufficient to charge the implantable device, 132; optionally thereafter, rotating the charging device while mounted in the carrier bonded to the patient's skin until the charging device is in a predetermined alignment with the implantable device for charging, 133; and charging the implanted device by allowing the charging device to remain in proximity to the implanted device supported by the carrier bonded to the patient's skin for a duration, 134. In some embodiments, the CD may be configured to provide charging regardless of rotational alignment or may be configured to adjust the rotational alignment of the charging coil as needed, making manual alignment by the patient potentially unnecessary.

14A-14C show schematic diagrams representing different charging device configurations that provide indicators or warnings to the patient to facilitate charging the implantable medical device by the charging device. Each configuration outputs a different indicator (usually an audio and/or tactile warning) to the patient that communicates aspects of the charging method to the patient. Typically, the configuration includes a unique indicator that indicates any or all of the following: proximity of the charging device to the implanted device, alignment of the charging device relative to a charging device suitable for charging, interruption of charging , and charging is complete.

Figure 14A shows a configuration that includes: a first indicator (such as three audible beeps) that indicates the proximity of the charging device to the IPG; a second indicator (such as a long or continuous tone), the second indicator is used to indicate that the charging device is directly on the IPG; a third alarm (such as a tactile vibration), the third alarm is used to indicate the proper rotation of the charging device relative to the IPG alignment; and a fourth alarm (such as a rising audible tone) to indicate that charging has begun. A fifth warning, such as a buzzing tone, may be used to indicate that charging has been interrupted. In any of the described embodiments, any of the aforementioned indicators described may be used as desired after an interruption is indicated, for example, if the charging device must be repositioned or realigned in order to resume Charge. A sixth warning, such as a falling tone, may be used to indicate that charging is complete. In any of the embodiments described herein, each of the above alerts is provided by the portable charging device based at least in part on measurements and determinations made by the charging device.

Figures 14B-14C illustrate additional configurations with more simplified use of indicators than the configuration of Figure 14A. The charger device configuration of Figure 14B utilizes the following: a first indicator (such as a long tone) that is used to indicate the alignment of the charging device with an IPG suitable for charging; a second indicator (such as a period bang), the second indicator is used to indicate that charging is taking place; a third indicator, such as a periodic vibration, is used to indicate that charging has been interrupted; and a fourth indicator, such as rising tone), the fourth indicator is used to indicate that charging has been completed. The charger device configuration of Figure 14C utilizes the following: a first indicator (such as a long tone) that is used to indicate the alignment of the charging device with an IPG suitable for charging; a second indicator (such as a period a combination of sexual vibrations and auditory tones (e.g., three beeps and a vibration that repeats every five seconds), the second indicator to indicate that charging has been interrupted; and a third indicator (e.g., a string Repetitive rising tone), the third indicator is used to indicate that charging has been completed. It should be appreciated that the embodiments described above are illustrative and that such configurations may utilize various types or combinations of alerts to communicate aspects of the charging process or method to the patient.

15 illustrates a method of facilitating transdermal charging of an implanted medical device with a portable charging device through the use of various indicators, according to various embodiments. In this example, the method includes: determining the proximity and/or alignment between the charging coil of the charger device and the implanted IPG, 150; utilizing the charger device output to indicate the proximity and/or suitable charging pair A first indicator of accuracy, 151; the charger device is used to charge the implantable IPG, 152; optionally, output a second indicator indicating charging, 153; if the charging is interrupted, then output the first indicator indicating that the charging has been interrupted three indicators; and determining that charging has been completed and outputting a fourth indicator indicating charging is complete, 155.

FIG. 16 illustrates a portable charging device 50 having a protruding circular portion 53 on which an indicator graphic 59 is disposed for visually representing the target alignment of the charging device 50 relative to the IPG. Such an indicator graphic 59 can be used as a training tool as well as a reminder to the user to enable consistent, accurate alignment while charging. In this embodiment, the indicator graphic 59 graphically represents the size and shape of the IPG in the target orientation by outlining the IPG. Graphic 59 is provided on the planar surface of protruding circular portion 53 that engages the patient's skin. Although in this embodiment the graphic 59 is shown as an outline of the IPG on the skin-engaging surface of the circular portion 53, it should be appreciated that such a graphic indicator may be included on various other surfaces (e.g., the top surface). or opposing surface) and may include various other graphics (eg, arrows, text) to represent the targeted alignment of the charging device on the patient.

In the foregoing specification, the invention has been described with reference to specific embodiments thereof, but those skilled in the art will recognize that the invention is not limited thereto. The various features and aspects of the invention described above may be used individually or together. In addition, the invention may be utilized in any number of environments and applications beyond those described herein without departing from the broader spirit and scope of the present description. Accordingly, the specification and drawings are to be regarded as illustrative rather than restrictive. It will be appreciated that the terms "comprising", "including" and "having" as used herein are specifically intended to be understood as open-ended terms of the art.

Claims (45)

1. a kind of rechargeable medical implant system, including：

Implantable medical device, the implantable medical device, which has, to be used for when the equipment is implanted in patient's body to described The rechargeable power supply that equipment is powered and the wireless power receiving unit with rechargeable power supply coupling；

Portable charging apparatus, has a wireless power transmission unit, the wireless power transmission unit be arranged to it is described The wireless power receiving unit magnetic couple of implantable devices, so as to be recharged to the rechargeable power supply；And

Carrier, can removedly it be coupled with the charging equipment, the carrier has the skin table for being used for being bonded to the patient The adhesive surface in face, wherein, surface of the adhesive surface not with the charging equipment contacts, and wherein, the bonding table Face includes biocompatible adhesive, and the biocompatible adhesive has enough bonding strengths to be bonded to the trouble The skin surface of person and at least in the duration inner support and institute for being enough to recharge the implantable medical device State the carrier of charging equipment coupling.

2. the system as claimed in claim 1, wherein, the wireless power transmission unit of the charging equipment includes charging wire Circle, the charge coil be arranged to when the charging equipment engages with the skin surface of the patient at least in part and When being positioned at least partially on the implantable medical device with the radio receiving unit magnetic couple, wherein, the load Body substantially flat seats against the charging equipment skin of the patient.

3. system as claimed in claim 2, wherein, the carrier includes one or more removable contact pin, it is one or The adhesive surface is disposed with multiple contact pin, each in one or more of contact pin the carrier be placed to By the patient skin the charging equipment couple when can move between the first location and the second location, wherein, described In first position, the skin of one or more of contact pin and the patient are spaced apart to promote the skin along the patient The charging equipment is manuallyd locate, and in the second place, one or more of contact pin be pushed into against The skin of the patient is to promote the carrier firm attachment in the duration of charge using the adhesive surface To the skin of the patient.

4. system as claimed in claim 3, wherein, one or more of contact pin are in the carrier and the charging equipment coupling Extended circumferentially over upon when connecing at least partly around the charging equipment, so as in the skin of the carrier binder to the patient The charging equipment is substantially flat seated against to the skin of the patient.

5. system as claimed in claim 3, wherein, the carrier includes the framework being connected to appended by one or more contact pin, its In, the framework defines mounting interface, and the charging equipment is removedly coupled at the mounting interface.

6. system as claimed in claim 5, wherein, the mounting interface of the carrier is arranged to set in the charging It is standby to allow when releasedly coupling with the carrier to can be manually rotated the charging equipment relative to the carrier.

7. system as claimed in claim 6, wherein, the mounting interface is configured with dimensional fits part, the dimensional fits Part has for allowing to rotate insufficient friction of the charging equipment when the charging equipment is by moment forces and being used for The charging equipment abundant friction that angle is fixed in the carrier is maintained when the charging equipment is static.

8. system as claimed in claim 6, wherein, the charging equipment includes circular or disc shell, it is described circular or Disc shell supports and/or encapsulated the wireless power transmission unit and at least in part in the prominent circular of the shell Associated charge coil in part.

9. system as claimed in claim 8, wherein, the framework of the carrier includes circular rings, and the installation connects Mouth includes the internal edge docked along the external margin of the ledge with the charging equipment of the circular rings Ridge.

10. system as claimed in claim 8, wherein, the mounting interface is arranged in buckle flexibly receive institute State the prominent circular portion of charging equipment.

11. system as claimed in claim 3, wherein, one or more of contact pin of the carrier are included in described first Three or more contact pin deflected between position and the second place.

12. system as claimed in claim 3, wherein, one or more of contact pin are by sufficiently rigid and flexible material shape Into flexibly to be overturn between the first position and the second place.

13. system as claimed in claim 5, wherein, the framework and one or more of contact pin are overall by polymeric material Formed.

14. a kind of carrier for portable charging apparatus, the portable charging apparatus is arranged to patient's body Implantable nerve stimulator enters percutaneous charging, and the charging equipment carrier includes：

Semi-rigid or rigid frame, it is arranged to removedly couple with the charging equipment, wherein, the framework includes opening Mouthful, when the charging equipment and the framework couple, a part for the charging equipment extends through the opening；And

One or more contact pin, it is attached to the framework and laterally stretches out from the opening of the framework, wherein, One or more of contact pin include adhesive surface, and the adhesive surface has biocompatible adhesive, the bio-compatible Property adhesive there is enough bonding strengths so as to be bonded to the skin surface of the patient and be enough to it is described implantation god The duration inner support recharged through stimulator and the carrier of charging equipment coupling.

15. charging equipment carrier as claimed in claim 14, wherein, each in one or more of contact pin is described Carrier can move between the first location and the second location with being placed against when the charging equipment of the patient skin couples It is dynamic, wherein, in the first position, the skin of one or more of contact pin and the patient be spaced apart to promote along The skin of the patient manuallys locate to the charging equipment, and in the second place, it is one or more of Contact pin is pushed into the skin against the patient to promote institute in the duration of charge using the adhesive surface Carrier firm attachment is stated to the skin of the patient.

16. charging equipment carrier as claimed in claim 15, wherein, the framework of the carrier includes circular rings, and One or more of contact pin of the carrier are included in three of elastic deflection between the first position and the second place Individual or more contact pin.

17. charging equipment carrier as claimed in claim 14, wherein, the opening is circle, and one or more of Contact pin extends circumferentially over upon at least partly around the opening, so as to be coupled to the carrier and described in the charging equipment The charging equipment is substantially flat maintained against to the skin of the patient when contact pin is bonded to the skin of the patient Skin.

18. charging equipment carrier as claimed in claim 14, wherein, the framework and one or more of contact pin are by polymerizeing Material is integrally formed.

19. charging equipment carrier as claimed in claim 14, wherein, one or more of contact pin are interconnected by the framework And it is formed between the first position and the second place by sufficiently rigid and flexible material and is flexibly overturn.

20. charging equipment carrier as claimed in claim 14, wherein, the carrier includes mounting interface, the carrier along The mounting interface is releasedly coupled to the charging equipment, and the mounting interface is arranged to can in the charging equipment Allow to can be manually rotated the charging equipment relative to the carrier when being coupled in the mounting interface to release.

21. charging equipment carrier as claimed in claim 20, wherein, the mounting interface of the carrier is arranged to adopt Constructed with snap-type and docked with the individual features of the charging equipment, so as to while allowing can be manually rotated the charging equipment The charging equipment is fixed to the carrier.

22. charging equipment carrier as claimed in claim 20, wherein, the mounting interface of the carrier is arranged to adopt Constructed with joint tongue type and docked with the individual features of the charging equipment, so as to while allowing can be manually rotated the charging equipment The charging equipment is fixed to the carrier.

23. charging equipment carrier as claimed in claim 20, wherein, mounting interface is resized to provide enough frictions So as to forbid being coupled in the rotation of the charging equipment in the carrier when the charging equipment is static.

24. a kind of method that implantable medical device to patient's body enters percutaneous charging, methods described include：

By the portable charging apparatus with shell and the charge coil being arranged therein with possessing biocompatible binder The carrier of one or more contact pin on surface removedly couples, and one or more of contact pin can be in first position and second Moved between putting；

When the charging equipment is in the carrier and one or more of contact pin are in the first position and institute State patient skin surface it is spaced apart when, non-invasively the basal surface of the charging equipment is engaged at least in part Against the skin surface of the patient；

The charging equipment is positioned, until its be positioned at least partially at it is on the implantable medical device or attached Closely；And

One or more of contact pin are moved into the second place from the first position, so that the adhesive surface connects Touch and be bonded to the skin of the patient to be enough in the duration for being enough to charge to the implanted equipment Inner support and the charging equipment of carrier coupling.

25. method as claimed in claim 24, wherein, performed using the single hand of the patient each in the following ：By the basal surface of the charging equipment and the skin engagement of the patient；The charging equipment is positioned； And one or more of contact pin are moved into the second place.

26. method as claimed in claim 25, wherein, one or more of contact pin include multiple contact pin, and by described in One or more contact pin move to the second place and performed in the following manner：Press at least one in the multiple contact pin Thus each contact pin in the multiple contact pin is moved to the second place by individual contact pin flexibly to overturn the carrier.

27. method as claimed in claim 24, wherein, positioning is carried out to the charging equipment until it is positioned at least in part On the implanted equipment or nearby include：It is attached in the implanted equipment along the skin surface of the patient Closely move the charging equipment to move, until charging equipment described in the charging equipment to patient's output indication is oriented properly On the implanted equipment or neighbouring first alerts.

28. method as claimed in claim 27, wherein, first warning is the sense of hearing and/or haptic user feedback.

29. method as claimed in claim 27, further comprises：The carrier is fixed in one or more of contact pin Rotate the charging equipment relative to the carrier during skin surface of the patient, until the charging equipment with it is described Implanted equipment is rotatably aligned.

30. method as claimed in claim 29, wherein, performed using the single hand of the patient each in the following ：By the basal surface of the charging equipment and the skin engagement of the patient；The charging equipment is positioned； The charging equipment is rotated relative to the carrier；And one or more of contact pin are moved into the second place.

31. method as claimed in claim 29, wherein, rotating the charging equipment includes：The charging equipment is rotated, until The second warning that charging equipment described in the charging equipment output indication is rightly aligned with the implanted equipment.

32. method as claimed in claim 31, wherein, second warning be different from the described first warning tactile and/ Or audio feedback.

33. method as claimed in claim 29, further comprises：

After after the duration of charge is complete and/or exported from the charging equipment to the patient and indicate charging complete After 3rd warning, the carrier and charging equipment are removed from the skin of the patient.

34. a kind of belt carrier for portable charging apparatus, the portable charging apparatus is arranged to patient's body Implantable nerve stimulator enter percutaneous charging, the belt carrier includes：

Extensible band, the extensible band have the corresponding coupling feature on each opposite end, and each opposite end is fitted It is used in and releasably couples to allow patient that the band is adjusted into stage casing as required；

Circular port, be arranged in the center section of the band, the circular port be resized so as to ordinatedly receive it is described just Take the protrusion circular portion of formula charging equipment；And

Semi-rigid or rigid frame, described semi-rigid or rigid frame defines the circular port and has mounting interface, described Mounting interface is adapted to removedly couple with the charging equipment, so that the prominent circle of the charging equipment Shape part projects through the circular port and is coupled in the charging equipment on the stage casing in the patient and dressed The band when engage the skin of the patient, wherein, the mounting interface surrounds the center that extends through the circular port Normal axis is axisymmetric, so as to allow the patient to be manually rotated to spy when the charging equipment and the band couple Fixed rotary alignment.

35. a kind of method that implantable medical device to patient's body enters percutaneous charging, methods described include：

Portable charging apparatus with shell and the charge coil being arranged therein and the belt carrier with circular port is removable Except ground couples, in coupling, the rounded bottom of the charging equipment extends partially across the circular port；

When the charging equipment is arranged in the carrier, by the basal surface of the charging equipment at least partly non-invasively Ground is engaged against the skin surface of the patient；

The charging equipment is positioned, until its be positioned at least partially at it is on the implantable medical device or attached Closely, as indicated by first sense of hearing from the charging equipment and/or haptic signal；

Corresponding coupling feature on opposite end by releasedly coupling the band adjusts the band；And

The charging equipment is can be manually rotated when the charging equipment is coupled in the band, until second sense of hearing and/or tactile The acceptable charging alignment of signal designation charging.

36. a kind of method that implantable medical device to patient's body enters percutaneous charging, methods described include：

Portable charger equipment is placed on the patient to promote the implantation nerve stimulation to the patient's body to enter Row charging；

The portable charger equipment is positioned, until charging described in the charging equipment to patient's output indication Equipment approaches or is appropriately positioned on the implanted equipment the first designator to be charged；

The portable charger is adjusted in response to the second designator that the instruction charging exported by the charging equipment is interrupted The position of equipment or the attached peripheral device of the support charger device；And

The charging equipment is removed after by the instruction of the 3rd of the charging equipment output indication charging complete.

37. method as claimed in claim 36, wherein, each designator in first, second, and third designator is Uniquely, so as to being readily recognized by the patient.

38. method as claimed in claim 36, wherein, each designator in first, second, and third designator is Aural alert and/or tactile alert.

39. method as claimed in claim 38, wherein, first warning includes pedal point tune.

40. method as claimed in claim 39, wherein, second designator includes periodic vibration and/or a string of minors Adjust.

41. method as claimed in claim 40, wherein, the 3rd designator includes one different from second designator Repeated minor of going here and there is adjusted.

42. method as claimed in claim 41, wherein, the 3rd designator includes a string of rising tones.

43. a kind of rechargeable medical implant system, including：

Implantable medical device, the implantable medical device, which has, to be used for when the equipment is implanted in patient's body to described The rechargeable power supply that equipment is powered and the wireless power receiving unit with rechargeable power supply coupling；

Portable charging apparatus, has a wireless power transmission unit, the wireless power transmission unit be arranged to it is described The wireless power receiving unit magnetic couple of implantable devices to be recharged to the rechargeable power supply, wherein, There is the portable charging apparatus skin for being used to engage the patient on the implantable medical device to promote to fill The plane surface of electricity, wherein, the portable charging apparatus includes the designator figure on the plane surface, the designator Figure represent the charging equipment relative to the implantable medical device target alignment consequently facilitating the patient to described Charging equipment is aligned.

44. rechargeable medical implant system as claimed in claim 43, wherein, the designator figure is in the target pair There is the size and dimension of the implantable medical device in standard.

45. rechargeable medical implant system as claimed in claim 43, further comprises：

Carrier, can removedly it be coupled with the charging equipment, the carrier has the skin table for being used for being bonded to the patient The adhesive surface in face, wherein, the adhesive surface includes biocompatible adhesive, and the biocompatible adhesive has foot Enough bonding strengths are to be bonded to the skin surface of the patient and at least to be enough to enter the implantable medical device The duration inner support that row recharges and the carrier of charging equipment coupling.